With 10 years in research and >30 in safety, Margaret is currently the Deputy EU Qualified Person for Pharmacovigilance at MSD Ltd. Activities include input to the EFPIA PV EWG, ICH, MedDRA (pre-ICH), the EMA EudraVigilance Steering Committee and the EWG, plus authoring papers on parasitology and drug safety

Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

Regulatory and R&D professional with extensive experience across a network of industry, government, academic and healthcare system partners and stakeholders. Broad range of expertise in all aspects of medicines and device research and development including evidence generation, licensing, manufacturing, market access and on-market support. Specific areas of expertise include clinical trials, biologics, real world evidence, paediatric drug development, medical devices, pharmacovigilance, CMC and regulatory policy and strategy development.

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

Anne Kehely is a Medical Fellow and Deputy Qualified Person for Pharmacovigilance at Lilly where she has worked for eighteen years. She is a Chemical Pathologist by training and was a consultant and Clinical Director at Ealing Hospital for five years prior to joining industry. She qualified as a doctor from Trinity College Dublin and did her post graduate training in Dublin and London.

Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

Tom Paternoster-Howe joined the EMA in 2004, where he has worked ever since. His work at the EMA has focused on the quality and analysis of data in Eudravigilance and he is currently the lead scientific administrator for both the Medical Literature Monitoring service & the Eudravigilance data management contract. Prior to joining the Agency, he worked for 3 years in the industry & at the MHRA in pharmacovigilance.

Mandeep initially joined the MHRA as a Good Clinical Practice (GCP) Inspector in October 2008. In 2011 she moved to an Operations role and is currently responsible for the GPvP (Good Pharmacovigilance Practice) Inspectorate. Prior to joining the MHRA, Mandeep worked for the pharmaceutical industry, the MHRA and the NHS. Mandeep has a BSc (Hons) in Pharmacology from King’s College London and is studying for an MSc in Public Health. Mandeep is also the current chair of the PIC/S GCP & GPvP Working Group.

Dr June Raine is the CEO of the Medicines and Healthcare products Regulatory Agency. Dr Raine trained in general medicine in Oxford after completing a Master’s degree by research in pharmacology. Her interest in drug safety led to a career in medicines regulation from 1985 onwards. She was Director of the Vigilance and Risk Management of Medicines division from 2006. Her experience includes chairing the European Pharmacovigilance Risk Assessment Committee (PRAC) on behalf of the European Medicines Agency for six years. She is also a member of the WHO Advisory Committee on Safety of Medicinal Products.

John Barber is since approximately 25 years in the pharmaceutical industry, the last 10 years in pharmacovigilance. He is the past President of the UK Pharmaceutical Information and Pharmacovigilance Association (PIPA)(2005-09), Lead on pharmacovigilance for the British Generic Manufacturers Association (BGMA) and a current member of the European Generics Association's (EGA) Pharmacovigilance Working Group leading the RMP work stream. His prior roles were with ICI Pharmaceuticals, Glaxo Wellcome, Roche and PharmaVentures, 2000 to 08, he was the Director of Scientific Affairs at Alliance Pharmaceuticals. He then became the Global Clinical Pharmacovigilance Manager at Glenmark Pharmaceuticals, 2008-10. Since 2010, he’s the QPPV at Dr Reddy’s.

After studies in clinical research and development, specialising in Clinical data management, Francois worked for pharmaceutical companies in various position in clinical data management. He joined the European Medicines Agency in 2009 where he works in the Data Standardisation and Analytics service of Information Management Division. He is the project manager of the EudraVigilance Auditable Requirements project, set-up to complete the implementation of the new Pharmacovigilance legislation and to deliver the new EudraVigilance system. He is also supporting all activities related to the data management and analysis of the EudraVigilance (EV) system in particular using the EudraVigilance Data Analysis System (EVDAS) and SAS.

Chris Foreman is the Deputy Chief Privacy Officer of the US-based Merck & Co., Inc. He is a lawyer, having spent 20 years in the Company’s Office of General Counsel, before joining the Global Privacy Office in Sept. 2018. Based in Brussels, Chris has practiced law in London, Washington DC, Istanbul, New York, Brussels and Moscow, focusing on pharmacovigilance, pharmaceutical regulations, trademarks and general corporate work.

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

Michelle is leading the International Pharmacovigilance organization at MSD. She has 25+ years of experience in the pharma industry and worked in clinical research and consulting prior to moving into pharmacovigilance (PV). Since joining MSD in 2002 she has performed various roles within PV including an EUQPPV support function, as well as prior regional operations roles in Asia Pacific and EMEA. Michelle has accountability for PV activities ex-US which consists of approx. 205 markets managed from 56 locations across the globe. Michelle is a part of the Global Clinical Safety and Pharmacovigilance Leadership Team, and works closely with HQ colleagues in the US. She is based in Europe.

Susana Perez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President, Global Head of Epidemiology at RTI Health Solutions. She leads a team of epidemiologists working in pharmacoepidemiology and risk management research pre and post-approval in Europe and North America. Prior positions include global head of epidemiology at several large R&D pharma companies. She is a Past President of the International Society for Pharmacoepidemiology, and Vice-Chair of the Steering Group of the EMA led European Network of Centers of Pharmacoepidemiology and Pharmacovigilance, ENCePP.

Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV. Sue works closely with the Global Patient Safety team and a network of local safety officers to provide oversight of patient safety across the EU. Sue sits on the Efpia Pharmacovigilance Expert Group and is an honorary Fellow of PIPA (Pharmaceutical Information and Pharmacovigilance Association). Prior to joining Amgen Sue spent 3 years at Eisai Europe Ltd as Head of International Pharmacovigilance and EU QPPV having previously held various roles in safety, medical information and marketing for GlaxoSmithKline and AstraZeneca operating at both the affiliate and global level. Sue holds a BSc (Hons) in Biochemistry and MSc in Immunology.

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented the UK on EMAs EudraVigilance Expert Working Group. Shelley now supports clients with QPPV, Risk Management, Inspection Readiness and implementation of global PV systems.

Peter got his medical degree from the Catholic University of Leuven in Belgium and until the end of 2003, Peter practised as a General Practitioner in the UK. In 2004, he joined Roche as a drug safety physician in the local organisation. Taking up roles with increasing responsibility, Peter was appointed Qualified Person for Pharmacovigilance for Roche in 2011. He left Roche at the end of 2014 to take a role at Daichii Sankyo and moved on to be the Head of Global Drug Safety & QPPV for Grunenthal. Peter has extensive experience in pre-approval and post-marketing pharmacovigilance.

Ilaria Del Seppia is the business project manager of the implementation of the electronic submission of information on medicinal product authorised in EU (known as Article 57 database) and the project manager for the implementation of the International Standards on Identification of Medicinal Product (i.e. ISO IDMP) as part as the Master Data (SPOR) Management activity at the Agency. Co-chair of the EMA joint Article 57 Implementation Working Group with EU industry associations since 2013, Ilaria has been appointed co-chair of the EU ISO IDMP Task Force with representatives from EU industry associations, software vendors and experts from the EU regulatory network to define the strategy for the implementation of the ISO IDMP in Europe.

Jolanta Gulbinovic is currently the Chief Expert, Head of the Unit for Cooperation with the EMA and International Relations and Professor at Dept. of Pathology, Forensic medicine and Pharmacology at the Vilnius University. She received the MD in paediatrics at Vilnius University and did the PhD on drug utilization in Lithuania. Furthermore, she had a training in Clinical Pharmacology at Karolinska Institute in Stockholm. After that she worked as a Clinical Pharmacologist at Vilnius university hospital for more than ten years and as a Clinical Assessor at the Swedish Medicines Control Agency for more than three years. Recently she has been elected to the executive board of the European association of clinical pharmacology and therapeutics.

Michael Richardson has many years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently Head of Bristol Myers Squibb’s Pharmacovigilance Function. Prior to this role he headed BMS and Eli Lilly’s Development and Medical Organization across Asia Pacific. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK as Medical Director.

Doris Stenver is the founder of Unique Advice and she is specialised in internal medicine and has a master degree in public administration. She is former Chief Medical Officer at the Danish Medicines Agency and former member of the EU Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public.

Lesley Wise has over 20 years of experience in pharmacovigilance both in medicines regulation at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology where she worked closely with colleagues to ensure a companywide approach to Benefit - Risk Management and to maintain compliance with regulatory requirements. Lesley has been working as an independent consultant to the pharmaceutical industry for the last seven years and has liaised regularly with regulators, including meetings with PRAC, CHMP and FDA.

MariaGrazia Zurlo, is the EUQPPV for Pfizer and heads Safety Strategy, Policy and Standards in Pfizer Worldwide Safety. Her responsibilities include the qualified person function, policies and standards as relates to the pharmacovigilance system, as well as pharmacovigilance quality management. She has over 25 years of experience in academy and in the pharmaceutical industry, in the areas of clinical research and clinical development of oncology medicinal products, project management and drug safety.

My background is one of a Nursing degree and Masters in Clinical Pharmacology. I have been in the Pharmaceutical Industry for almost 30 years. Most spent in Pharmacovigilance in all areas, globally and locally. I spent some time as Director Regulatory Operations. My career has been spent mainly in Big Pharma although I have covered most therapeutic areas including generics, biosimilars, innovators etc. I have been a deputy QPPV for 8 years and most recently in Novartis since 2018. I have experience in different external committees and industry partnerships.

In her position as Head of Service E, Irene is responsible for ensuring the quality and consistency of PRAC recommendations, CHMP opinions and CMDh positions and their respective assessment reports for PSURs, PSUSAs and PASS procedures. In addition, the service provides regulatory and procedural support on these procedures to the network, as well as external stakeholders. Irene is also the EMA business lead of the PSUR repository project.

Noha gained a Ph.D in Pharmaceutics in 1990 from King’s Collage, University of London. She joined Eli Lilly in 1990 as Research Scientist. Among other jobs she worked as Head of Clinical Trial Manufacturing and Supplies, Pharmaceutical Project Management working on programs initiated by Research Centers in EW and Hamburg. Noha became Manager, GPS Quality in 2004 with responsibility for Europe, Asia Pacific and Japan. 2009 she became Senior Director of Quality in Global Patient Safety with responsibility to establish the quality strategies and processes that will support design, execution, and monitoring of risk management plans, including global risk minimization. 2011 she became the head of the EU Pharmacovigilance group located in the UK.